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NCT04619420

NCT04619420
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been gradually and progressively experiencing memory or thinking problems for at least the past 6 months, confirmed by both you and someone who knows you well, and your memory difficulties fall within a specific mild range measured by a standard assessment called the CDR (confirm with trial site)
  • A brain scan (tau PET scan) has shown a positive result, indicating a specific protein buildup associated with Alzheimer's disease
  • You are able to read and write, and have had at least 5 years of formal schooling
  • You have a trusted person (such as a family member or close friend) who can read and write well enough to participate alongside you and is likely to stay involved throughout the whole study
  • Male participants must agree not to donate sperm during the study and for up to 16 weeks after their last dose of the study treatment

Who may not be able to join:

  • Your Alzheimer's symptoms are at a more advanced stage, based on a standard assessment score of 2 or higher at the start of the study (confirm with trial site)
  • Your memory or thinking problems are thought to be caused by a condition other than Alzheimer's disease, such as Parkinson's disease, stroke-related issues, head injury, or alcohol or drug use
  • You score above a certain level on a standard depression questionnaire for older adults (confirm with trial site)
  • You score above a certain level on a test that checks whether mini-strokes or reduced blood flow to the brain may be contributing to your symptoms (confirm with trial site)
  • You have been taking medications that affect the brain or nervous system for less than 2 months, or you stopped such a medication less than 2 months ago — these medications need to have been at a stable dose for at least 2 months before the study begins
  • You regularly take benzodiazepines (a type of medication often used for anxiety or sleep)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Janssen Research & Development, LLC
Registry
clinicaltrials_gov
Start date
6 January 2021
Est. completion
17 October 2025

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇯🇵 Japan 🇳🇱 Netherlands 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov